The IDx-DR software is designed for use by primary care physicians and other health providers who treat patients with diabetes. The goal, IDx says, is for these providers to screen adult patients without requiring an eye specialist to scan images for signs of DR.

Images of the patient’s retina are captured by a Topcon NW400 camera and uploaded to a cloud server, where the IDx-DR software resides. The software autonomously interprets the images and returns one of two possible results: ‘More than mild diabetic retinopathy detected: refer to an eye care professional’ or ‘negative for more than mild diabetic retinopathy; rescreen in 12 months.’

A multi-center trial of the device in more than 900 adults with diabetes revealed a sensitivity and specificity of 87.3% and 89.5%, respectively.

The FDA's decision comes about 2 months after the agency granted breakthrough device status for IDx-DR and expedited the device’s review. The speedy approval is part of FDA Commissioner Scott Gottlieb’s ongoing efforts to fast-track generic drugs, biosimilars and other products. The agency will continue to advance safe and effective digital health devices that could boost access to health care, according to a statement by Malvina Eydelman, MD, who oversees the FDA’s division of ophthalmic, and ear, nose and throat devices.